Actively Recruiting
Labor Induction in Low-risk Nulliparous Women at 39 Weeks of Gestation to Reduce Cesarean: A Randomized Trial of Induction Versus Expectant Management in France (FRENCH-ARRIVE)
Led by University Hospital, Bordeaux · Updated on 2025-02-11
4200
Participants Needed
1
Research Sites
320 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
The recent ARRIVE trial conducted in United States of America in 2014-2017 demonstrates that elective induction of labor at 39 weeks for nulliparous women did result in a significantly lower frequency of cesarean delivery with no significant differences of adverse perinatal outcomes. But the expected benefits of elective labor induction at 39 weeks have to be confirmed in other settings outside US before considering routine induction of labor for all low-risk nulliparous women at 39 weeks of gestation worldwide.
CONDITIONS
Official Title
Labor Induction in Low-risk Nulliparous Women at 39 Weeks of Gestation to Reduce Cesarean: A Randomized Trial of Induction Versus Expectant Management in France (FRENCH-ARRIVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 218 years
- Nulliparous women (no previous pregnancy beyond 20 weeks)
- Singleton pregnancy (not twins or multiples)
- Gestational age between 37 weeks 0 days and 38 weeks 6 days based on first trimester ultrasound
- Affiliated with or beneficiary of a health security system
- Signed informed consent
You will not qualify if you...
- Gestational age at first ultrasound greater than 14 weeks
- Planned induction of labor before 40 weeks 5 days
- Planned cesarean delivery or contraindication to labor
- Breech baby position
- Multiple pregnancy
- Signs of labor such as regular painful contractions with cervical change
- Fetal death or major known fetal anomaly
- Use of heparin or low-molecular weight heparin during pregnancy
- Placenta previa, accreta, or vasa previa
- Active vaginal bleeding greater than bloody show
- Ruptured membranes
- Cerclage in current pregnancy
- Known low amniotic fluid levels
- Fetal growth restriction (estimated fetal weight below 10th percentile)
- Known HIV positivity
- Major maternal medical illnesses increasing pregnancy risk (e.g., diabetes, lupus, hypertension, heart or kidney disease)
- Refusal of blood products
- Contraindication to oxytocin
- Participation in another interventional labor or delivery study
- Delivery planned outside study network site
- History of uterine surgery such as myomectomy or metroplasty
- Legal protection status
- Poor understanding of French language
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
Research Team
L
Loic Sentilhes, MD, PhD
CONTACT
H
Hugo Madar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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